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A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION)
Scottsdale/Phoenix, Ariz.
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
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A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD) (BLISSc-ILD)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the effectiveness and safety of belimumab compared to placebo in adults with systemic sclerosis (SSc) associated interstitial lung disease (ILD).
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A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating The Safety And Efficacy Of Pirfenidone Solution For Inhalation (AP01) In Participants With PPF
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
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Assessing and validating the psychometric properties of the CRISTAL PRO through an online registry
Scottsdale/Phoenix, Ariz.
The purpose of this study is to validate the CRISTAL patient-reported outcome (PRO) where patients will complete PROs at baseline and again at 6 months. The PRO includes survey items designed to assess limited cutaneous systemic sclerosis (lcSSc) symptoms and experiences from a patient perspective.
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A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to investigate the effect of nerandomilast on the extent of pulmonary involvement from baseline to Week 26 as assessed with quantitative interstitial lung disease (QILD) score in quantitative high-resolution computed tomography (qHRCT). The primary treatment comparison is as randomised, including all data collected until Week 26 regardless of treatment discontinuation, start of restricted medication, changes in background IS therapies, or initiation of nintedanib.
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A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION)
Jacksonville, Fla.
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
Closed for Enrollment
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A Double Blind, Randomized, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MK-7240/PRA023 In Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (ATHENA-SSc-ILD)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
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A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis (DAISY)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this multinational, randomized, placebo-controlled, and double blind study is to evaluate the safety and efficacy of subcutaneous (SC) anifrolumab in adult patients with systemic sclerosis (SSc), who may be taking one or a combination of protocol specified standard therapies. Following 52-weeks of double-blind, placebo-controlled treatment, a 52-week open-label treatment period is included to assess long-term safety in Systemic Sclerosis (SSc).
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Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory Trial (MINT)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD).
Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung. This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices. The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine).
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